Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2026-01-01 @ 11:51 AM
Study NCT ID:
NCT05914766
Status:
RECRUITING
Last Update Posted:
2025-05-18
First Post:
2023-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized to either the intervention or enhanced usual care. Randomization will be stratified by treatment sequence (e.g., chemotherapy first vs. concurrent chemoradiation first).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-14', 'studyFirstSubmitDate': '2023-06-13', 'studyFirstSubmitQcDate': '2023-06-13', 'lastUpdatePostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-05-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of participants retained in the intervention (feasibility)', 'timeFrame': '4 weeks', 'description': 'The primary outcome will be feasibility, defined as ≥60% retention of participants over the four-week intervention.'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients enrolled on the study (feasibility)', 'timeFrame': '12 weeks', 'description': 'A secondary feasibility outcome will be defined as ≥60% enrollment among all eligible patients'}, {'measure': 'Proportion of participants reporting acceptability of the intervention (acceptability)', 'timeFrame': '12 weeks', 'description': 'A secondary outcome of acceptability will be defined as ≥80% of participants in the intervention arm reporting Client Satisfaction Questionnaire (CSQ-8) scores of ≥20 (scale from 8-32, higher scores indicate higher satisfaction).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['total neoadjuvant therapy', 'locally advanced rectal cancer', 'self efficacy', 'psychoeducational', 'multimodality treatment'], 'conditions': ['Rectal Cancer', 'Self Efficacy']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the feasibility and acceptability of conducting a randomized trial of a brief psychoeducational intervention versus enhanced usual care for patients with locally advanced rectal cancer who are initiating neoadjuvant multimodality treatment.', 'detailedDescription': 'This is a randomized controlled trial that is split into two phases. Study Phase I tested the feasibility and acceptability of a study evaluating a psychoeducational intervention relative to a control condition for improving self-efficacy in patients with locally advanced rectal cancer initiating multimodality treatment. This phase enrolled 20 participants.\n\nStudy Part 2 was initially planned as an adequately powered RCT to evaluate intervention efficacy for enhancing patient self-efficacy for managing treatment-related challenges and maintaining quality of life. Due to the substantial refinements that were made to the PATHWAYS intervention and study procedures after Study Part 1, we have elected to change Study Part 2 to a second pilot randomized controlled trial to evaluate the feasibility and acceptability of the refined PATHWAYS study among a larger group of patients (n=60).\n\nParticipants in the intervention arm will be invited to receive the PATHWAYS intervention, including 4 coaching sessions with a study clinician focused on information and support related to multimodality treatment for LARC. Participants in the control arm will receive an information resource guide that is tailored for patients with LARC.\n\nIt is expected that about 80 people will take part in this research study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age≥18 years\n2. Within 8 weeks after documented decision to pursue multi-modality therapy for newly diagnosed LARC (i.e., stage II or III disease)\n3. Able to complete study procedures English or with the assistance of an interpreter\n\nExclusion Criteria:\n\n1. Comorbid health condition that would interfere with study participation, as identified by cancer care team\n2. Has undergone treatment for a prior colorectal cancer'}, 'identificationModule': {'nctId': 'NCT05914766', 'acronym': 'PATHWAYS', 'briefTitle': 'An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'PATHWAYS: An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer', 'orgStudyIdInfo': {'id': '23-115'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Phase I: PATHWAYS Intervention', 'description': 'Participants assigned to the PATHWAYS Intervention will receive: 1) four coaching sessions, 2) a comprehensive patient education guidebook, and 3) a coaching session workbook.', 'interventionNames': ['Behavioral: PATHWAYS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Study Phase I: Enhanced Usual Care', 'description': 'Participants assigned to the enhanced usual care will receive: 1) an information resource guide for navigating information online.', 'interventionNames': ['Other: Enhanced usual care']}, {'type': 'EXPERIMENTAL', 'label': 'Study Phase II: PATHWAYS Intervention', 'description': 'Participants assigned to the PATHWAYS Intervention will receive: 1) four coaching sessions and 2) a comprehensive patient education guidebook. The intervention has been modified and refined based on feedback from Study Phase I.', 'interventionNames': ['Behavioral: PATHWAYS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Study Phase II: Enhanced Usual Care', 'description': 'Participants assigned to the enhanced usual care will receive: 1) an information resource guide for navigating information online.', 'interventionNames': ['Other: Enhanced usual care']}], 'interventions': [{'name': 'PATHWAYS', 'type': 'BEHAVIORAL', 'description': 'The PATHWAYS intervention is a psychoeducational intervention comprised of four behavioral coaching sessions and a patient education guidebook.', 'armGroupLabels': ['Study Phase I: PATHWAYS Intervention', 'Study Phase II: PATHWAYS Intervention']}, {'name': 'Enhanced usual care', 'type': 'OTHER', 'description': 'The enhanced usual care condition consists of an information resource guide.', 'armGroupLabels': ['Study Phase I: Enhanced Usual Care', 'Study Phase II: Enhanced Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kelsey Lau-Min, MD, MSCE', 'role': 'CONTACT', 'email': 'klau-min@mgh.harvard.edu', 'phone': '617-724-4000'}, {'name': 'Kelsey Lau-Min, MD, MSCE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christo Manz, MD, MSHP', 'role': 'CONTACT', 'email': 'christopher_manz@dfci.harvard.edu', 'phone': '617-632-3315'}, {'name': 'Christopher Manz, MD, MSHP', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Kelsey Lau-Min, MD, MSCE', 'role': 'CONTACT', 'email': 'klau-min@mgh.harvard.edu', 'phone': '617-724-4000'}], 'overallOfficials': [{'name': 'Kelsey Lau-Min, MD, MSCE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Data can be shared no earlier than 1 year following the date of publication', 'ipdSharing': 'YES', 'description': 'The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \\[contact information for Sponsor Investigator or designee\\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.', 'accessCriteria': 'Contact the Partners Innovations team at link below'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kelsey S. Lau-Min, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}